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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0433
Device Problems Kinked (1339); Occlusion Within Device (1423); Pumping Stopped (1503); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the iab pump (iabp) stopped pumping while in use on a patient and a "restriction in iab circuit" alarm was generated.The catheter was noted to have a large amount of clear fluid.A getinge field service engineer (fse) went to the customer site to the service the iabp and stated the iabp stopped pumping during use.The fse found the iab to be kinked as well as clotted.The fse performed all functional and electrical safety tests on the iabp and no problem was found.The iabp passed all tests and is cleared for clinical use.There was no reported injury to the patient.The date of the event is unknown.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the iab pump (iabp) stopped pumping while in use on a patient and a "restriction in iab circuit" alarm was generated.The catheter was noted to have a large amount of clear fluid.A getinge field service engineer (fse) went to the customer site to the service the iabp and stated the iabp stopped pumping during use.The fse found the iab to be kinked as well as clotted.The fse performed all functional and electrical safety tests on the iabp and no problem was found.The iabp passed all tests and is cleared for clinical use.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information: "date of event" changed from: blank to: (b)(6) 2018.Removed statement "the date of the event is unknown".Removed unknown and in.Added product name.Added lot #, catalog #, serial #, and expiration date.Added manufacture date device evaluation: the product was returned with the membrane completely unfolded and blood found on the exterior of the catheter and between the catheter and the sheath.The extender tubing was also returned with the syringe attached.Small amount of clear fluid was observed inside the syringe.No clear fluid or blood was detected inside the iab catheter.Two kinks were found on the catheter tubing approximately 40.6cm and 40.9cm from the iab tip.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a laboratory 0.018¿ guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was unable to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete auto fill cycle.The iab pumped normally and no alarm sounded from the pump.Alarm, iab catheter restriction & kink: the evaluation determined there was a kink in the catheter.It is difficult to determine when or how a kink in the catheter occurs.Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause inflation difficulty or an alarm.We were unable to duplicate the reported alarm.However the evaluation confirmed the reported kink.Clotted iab: the evaluation confirmed the reported clotted iab.Blood clotting within the inner lumen will seal the passage.It is difficult to determine when the occlusion occurs, however, if this occurs during the procedure it will be impossible to flush or aspirate through the inner lumen.It can also cause poor or no pressure waveform and guide wire insertion difficulty.Clear fluid in iab: an evaluation of the product was unable to confirm the reported clear fluid in iab.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).
 
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Brand Name
SENSATION 7FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7471664
MDR Text Key106979476
Report Number2248146-2018-00290
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/16/2020
Device Catalogue Number0684-00-0433
Device Lot Number30000563110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Device AgeYR
Date Manufacturer Received05/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
Patient Weight84
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